The SAPIEN 3 TAVI Advantage
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- Clarissa Turner
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1 Edwards SAPIEN 3 Valve The SAPIEN 3 TAVI Advantage...
2 The SAPIEN 3 TAVI Advantage The clear choice for your patients and your TAVI program Advanced valve and system designed to simplify procedures Consistent deployment and performance Unprecedented evidence for outcomes that matter * The PARTNER II Trial intermediate-risk cohort 30-day unadjusted clinical event rates for TAVI with the SAPIEN 3 valve, AT population (n=1077). 1. Thourani V, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: A propensity score analysis. Lancet. 2016;387: See the clinical difference All-cause mortality1* 75 Disabling stroke1* Lower than surgery1 Backed by landmark clinical evidence, the SAPIEN 3 transcatheter heart valve is designed to minimise the risk of complications, providing a proven clinical experience for your patients and your evolving TAVI program.
3 Reduced procedural complexity with simplified access, delivery, and deployment. First-time deployment accuracy1 >99 Low-Profile Sheath Controlled Articulation 14F/5.5mm* access without sheath exchanges The only commercially available transcatheter heart valve to offer controlled articulation Positioned in the intended location 96.6 No, trace or mild PVL2 No severe PVL Stable, Precise Deployment *For valve sizes 20, 23, and 26mm. Reliable Sealing 1. The PARTNER II Trial intermediate-risk cohort 30-day unadjusted clinical event rates for TAVI with the SAPIEN 3 valve, AT population (n=1077). 2. Kodali S, Thourani VH, White J, et al. Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis. Eur Heart J Jul 21;37(28):
4 Outcomes that matter. Backed by unprecedented evidence, the SAPIEN 3 valve continues to transform today s treatment of severe aortic stenosis. Propensity-matched analysis confirms the SAPIEN 3 valve clinical performance in a real-world population3 30-Day All-Cause Mortality (TF) Day All Stroke (TF) 20 P-value = All-cause mortality1* 1.0 Disabling stroke 1* 15 O:E = 0.17 O:E = 0.20 O:E = Trial TVT-R Trial CAP TVT-R STS # Pts # Sites PARTNER II S3i Trial PARTNER II S3i CAP TVT Registry N = (2014) N = ( ) N = 1,956 ( ) All-Cause Mortality () All Stroke () New Pacemaker () Major Vasc. Comps. () [2,4] 2.04 [2,3] 2.04 [2,3] Day Clinical Outcomes Propensity-Matched TF Cohort Designed to allow future coronary access Length of stay (Median [IQR]) PVL Moderate/Severe () 1. Thourani V, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: A propensity score analysis. Lancet. 2016;387: Douglas, et al. Longitudinal Hemodynamics of Transcatheter and Surgical Aortic Valves in the PARTNER Trial. JAMA Cardiology Tuzcu, E. Real World Outcomes of TAVR with the SAPIEN-3 Valve in Intermediate Risk Patients: Comparison of Data from the TVT Registry with PARTNER S3 Studies. Presented at EuroPCR 2018, 22 May Paris, France. 4. Site reported and unadjudicated Low new permanent pacemaker rates1* Excellent long-term durability 2 P-value = * The PARTNER II Trial intermediate-risk cohort 30-day unadjusted clinical event rates for TAVI with the SAPIEN 3 valve, AT population (n=1077).
5 The SAPIEN 3 TAVI Advantage The clear choice for your patients and your TAVI program. Advanced valve and system designed to simplify procedures Consistent deployment and performance Unprecedented evidence for outcomes that matter Discover the SAPIEN 3 TAVI Advantage SAPIEN3TAVIAdvantage.com For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions, and adverse events. Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity. Material for distribution only in countries with applicable health authority product registrations. Material not intended for distribution in USA or Japan. Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device. Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, PARTNER, PARTNER II, SAPIEN and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation Edwards Lifesciences Corporation. All rights reserved. E8356/07-18/THV Edwards Lifesciences Route de l Etraz 70, 1260 Nyon, Switzerland edwards.com
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